Rotator Cuff TearsNCT05988541
Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.
A study testing Ultrasonography imaging, American Shoulder and Elbow Surgeons (ASES) Score and The Constant-Murley score (CMS) in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Tartu University Hospital at 1 site in Estonia.
Trial summary
The study gives an overview of surgically treated rotator cuff injury patients in Tartu University Hospital Sports Traumatology Centre during 2013-2019 and evaluates the integrity of rotator cuff at minimum 5 years after atraumatic rotator cuff tendon repair. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- What is being tested?
- Ultrasonography imaging, American Shoulder and Elbow Surgeons (ASES) Score and The Constant-Murley score (CMS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEstonia
- Study dates
- 3 Oct 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients underwent rotator cuff repair by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019.
- Subject gives an informed consent and is willing to come for one outpatient visit.
Who cannot join
- Patients who underwent rotator cuff repair for traumatic tears are excluded from clinical assessment (stage II).
- Patients who underwent revision surgery are excluded from clinical assessment (stage II).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overview of Surgically Treated Rotator Cuff Injury Patients and Rotator Cuff Integrity 5 Years After Atraumatic Rotator Cuff Tendon Repair.
The study gives an overview of surgically treated rotator cuff injury patients in Tartu University Hospital Sports Traumatology Centre during 2013-2019 and evaluates the integrity of rotator cuff at minimum 5 years after atraumatic rotator cuff tendon repair.
First stage of the study describes the study population, etiology of the injury (traumatic/atraumatic) and aims to answer the question whether the arthroscopic findings are in line with the preoperative imaging studies or not.
Read more
Second stage of the study focuses on atraumatic tendon tears assessing structural integrity of the tendons 5 years after repair using ultrasound imaging. The main question is - does the findings correlate with clinical outcomes and patient satisfaction.
Participants of the second phase of the study will be asked for an appointment to have their shoulders examined with ultrasonography and clinical outcomes are measured using the American Shoulder and Elbow Surgeons (ASES) Score, The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and The Constant-Murley score (CMS).
Read the detailed description
High numbers of re-tear after rotator cuff surgery have been shown, though not always influencing patient satisfaction. If there is an atraumatic tendon tear, the risk of having a contralateral rotator cuff tendon tear is high.
The aim is to study surgically treated rotator cuff injury patients 5 years after repair to evaluate tendon integrity on ultrasonography and answer the question do the findings correlate with functionality and patient satisfaction. It has been shown that people over the age of 66 who have been diagnosed with rotator cuff tendon tear, have up to 50 % chance of having a rotator cuff tendon tear in contralateral shoulder (Yamaguchi, et al. 2006). Therefore the study will evaluate the function and the integrity of the rotator cuff in both shoulders.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- Being tested
- Ultrasonography imaging, American Shoulder and Elbow Surgeons (ASES) Score, The Constant-Murley score (CMS), The Disabilities of the Arm, Shoulder and Hand (DASH)
- Keywords
- rotator cuff injury, rotator cuff tears, sonography, shoulder injuries, atraumatic tears, shoulder pathology, shoulder ultrasound
- Medical subject headings
- Rotator Cuff Injuries, Rupture, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography imagingDiagnostic test
Ultrasonography: rotator cuff tendons (supraspinatus, infraspinatus, subscapularis) integrity, long head of the biceps tendon integrity and location, SASD (subacromial-subdeltoid) bursitis, synovitis and muscle atrophy.
American Shoulder and Elbow Surgeons (ASES) ScoreDiagnostic test
The patient self-assessment (pASES) includes 6 pain items and 10 functional items that are shoulder specific (Angst, 2008).
The pASES form has 3 sections: pain, instability, ADLs (Goldhahn, 2008).
- Pain section: 4 questions with yes/no responses, 1 question covering number of pain tablets per day, and a VAS (visual analogue scale) from 0 (no pain) to 10 (worst pain).
- Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)).
- Activities of daily living (ADLs): Each shoulder is included (affected/non affected), 10 items, with a 4 point ordinal scale, range: 0 (unable to perform activity) to 3 (no difficulty in doing activity) (Goldhahn 2008).
The Constant-Murley score (CMS)Diagnostic test
The test is divided into four subscales: pain (15 points), activities of daily living (ADL) (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
The Disabilities of the Arm, Shoulder and Hand (DASH)Diagnostic test
30-item self-report questionnaire designed to assess symptoms and function of the entire upper extremity.
Total scores range from 0 (minimum) to (100) maximum.
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic rotator cuff tendon repair | Other | Ultrasonography imaging of the operated shoulder Receives: Diagnostic Test: Ultrasonography imaging; Diagnostic Test: American Shoulder and Elbow Surgeons (ASES) Score; Diagnostic Test: The Constant-Murley score (CMS); Diagnostic Test: The Disabilities of the Arm, Shoulder and Hand (DASH) |
| Contralateral shoulder | Other | Ultrasonography imaging of the contralateral shoulder Receives: Diagnostic Test: Ultrasonography imaging; Diagnostic Test: American Shoulder and Elbow Surgeons (ASES) Score; Diagnostic Test: The Constant-Murley score (CMS); Diagnostic Test: The Disabilities of the Arm, Shoulder and Hand (DASH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography
Integrity of the rotator cuff tendons
Measured: 5 years after primary repair
Secondary outcomes (3)
American Shoulder and Elbow Surgeons (ASES) score
The higher the score, the better the outcome.
Measured: 5 years after primary repair
Constant-Murley score (CMS)
The higher the score, the higher the quality of the function.
Measured: 5 years after primary repair
The Disabilities of the Arm, Shoulder and Hand (DASH)
The higher the score, more severe disability.
Measured: 5 years after primary repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start3 Oct 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tartu
- Responsible party
- Sponsor
- Investigators
- Tiina Tikk, MD, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988541
- Sponsor's protocol ID
- Tikk2023
- Status last verified
- Mar 2025
- First submitted
- 4 Aug 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overview of Surgically Treated Rotator Cuff Injury Patients and Rotator Cuff Integrity 5 Years After Atraumatic Rotator Cuff Tendon Repair.
- ClinicalTrials.gov ID
- NCT05988541
- Acronym / sponsor ID
- Tikk2023
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- Keywords
- rotator cuff injury, rotator cuff tears, sonography, shoulder injuries, atraumatic tears, shoulder pathology, shoulder ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- University of Tartu
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study gives an overview of surgically treated rotator cuff injury patients in Tartu University Hospital Sports Traumatology Centre during 2013-2019 and evaluates the integrity of rotator cuff at minimum 5 years after atraumatic rotator cuff tendon repair.
First stage of the study describes the study population, etiology of the injury (traumatic/atraumatic) and aims to answer the question whether the arthroscopic findings are in line with the preoperative imaging studies or not.
Second stage of the study focuses on atraumatic tendon tears assessing structural integrity of the tendons 5 years after repair using ultrasound imaging. The main question is - does the findings correlate with clinical outcomes and patient satisfaction.
Participants of the second phase of the study will be asked for an appointment to have their shoulders examined with ultrasonography and clinical outcomes are measured using the American Shoulder and Elbow Surgeons (ASES) Score, The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and The Constant-Murley score (CMS).
Detailed description
High numbers of re-tear after rotator cuff surgery have been shown, though not always influencing patient satisfaction. If there is an atraumatic tendon tear, the risk of having a contralateral rotator cuff tendon tear is high.
The aim is to study surgically treated rotator cuff injury patients 5 years after repair to evaluate tendon integrity on ultrasonography and answer the question do the findings correlate with functionality and patient satisfaction. It has been shown that people over the age of 66 who have been diagnosed with rotator cuff tendon tear, have up to 50 % chance of having a rotator cuff tendon tear in contralateral shoulder (Yamaguchi, et al. 2006). Therefore the study will evaluate the function and the integrity of the rotator cuff in both shoulders.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atraumatic rotator cuff tendon repair | Other | Diagnostic Test: Ultrasonography imaging, Diagnostic Test: American Shoulder and Elbow Surgeons (ASES) Score, Diagnostic Test: The Constant-Murley score (CMS), Diagnostic Test: The Disabilities of the Arm, Shoulder and Hand (DASH)Ultrasonography imaging of the operated shoulder |
| Contralateral shoulder | Other | Diagnostic Test: Ultrasonography imaging, Diagnostic Test: American Shoulder and Elbow Surgeons (ASES) Score, Diagnostic Test: The Constant-Murley score (CMS), Diagnostic Test: The Disabilities of the Arm, Shoulder and Hand (DASH)Ultrasonography imaging of the contralateral shoulder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients underwent rotator cuff repair by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019.
- Subject gives an informed consent and is willing to come for one outpatient visit.
Key exclusion criteria (2 listed)
- Patients who underwent rotator cuff repair for traumatic tears are excluded from clinical assessment (stage II).
- Patients who underwent revision surgery are excluded from clinical assessment (stage II).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonography imagingUltrasonography: rotator cuff tendons (supraspinatus, infraspinatus, subscapularis) integrity, long head of the biceps tendon integrity and location, SASD (subacromial-subdeltoid) bursitis, synovitis and muscle atrophy. | Diagnostic test | Atraumatic rotator cuff tendon repair, Contralateral shoulder |
| American Shoulder and Elbow Surgeons (ASES) ScoreThe patient self-assessment (pASES) includes 6 pain items and 10 functional items that are shoulder specific (Angst, 2008). The pASES form has 3 sections: pain, instability, ADLs (Goldhahn, 2008). 1. Pain section: 4 questions with yes/no responses, 1 question covering number of pain tablets per day, and a VAS (visual analogue scale) from 0 (no pain) to 10 (worst pain). 2. Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)). 3. Activities of daily living (ADLs): Each shoulder is included (affected/non affected), 10 items, with a 4 point ordinal scale, range: 0 (unable to perform activity) to 3 (no difficulty in doing activity) (Goldhahn 2008). | Diagnostic test | Atraumatic rotator cuff tendon repair, Contralateral shoulder |
| The Constant-Murley score (CMS)The test is divided into four subscales: pain (15 points), activities of daily living (ADL) (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). | Diagnostic test | Atraumatic rotator cuff tendon repair, Contralateral shoulder |
| The Disabilities of the Arm, Shoulder and Hand (DASH)30-item self-report questionnaire designed to assess symptoms and function of the entire upper extremity. Total scores range from 0 (minimum) to (100) maximum. | Diagnostic test | Atraumatic rotator cuff tendon repair, Contralateral shoulder |
Primary outcome
Ultrasonography
Time frame: 5 years after primary repair
Integrity of the rotator cuff tendons
3 secondary outcomes
American Shoulder and Elbow Surgeons (ASES) score
Time frame: 5 years after primary repair
Constant-Murley score (CMS)
Time frame: 5 years after primary repair
The Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 5 years after primary repair
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiina Tikk, MD principal investigator
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography imaging, American Shoulder and Elbow Surgeons (ASES) Score and The Constant-Murley score (CMS) in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Tartu University Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonography (time frame: 5 years after primary repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.